ID

19265

Beschrijving

Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT00088478

Link

https://clinicaltrials.gov/show/NCT00088478

Trefwoorden

Versies (1)
  1. 16-12-16 16-12-16 -
Geüploaded op

16 december 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00088478

Engels

Eligibility Schizophrenia NCT00088478

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have schizophrenia and be experiencing a psychotic episode
Beschrijving

Schizophrenia | Psychotic episode

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0338614
each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
Beschrijving

Comprehension Sufficient Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0205410
UMLS CUI [1,3]
C0525058
UMLS CUI [2]
C0021430
patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
Beschrijving

Study Subject Participation Status | Investigational New Drugs | olanzapine

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0171023
female patients must not be pregnant or breast-feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Beschrijving

Genderr Medical condition | Gender Medical condition Serious | Gender Medical condition Unstable | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3843040
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3843040
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C3843040
UMLS CUI [3,3]
C0443343
UMLS CUI [4]
C0036341
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
Beschrijving

olanzapine Therapeutic procedure Resistant to

Datatype

boolean

Alias
UMLS CUI [1,1]
C0171023
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332325
one or more seizures without a clear and resolved etiology is exclusionary. however, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
Beschrijving

Seizures Quantity | Etiology Unresolved

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1314792
UMLS CUI [2,2]
C0443342
treatment with clozapine within 4 weeks prior to visit 1
Beschrijving

Clozapine

Datatype

boolean

Alias
UMLS CUI [1]
C0009079
dsm-iv or dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days
Beschrijving

Substance Dependence | Nicotine Dependence | Caffeine dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038580
UMLS CUI [2]
C0028043
UMLS CUI [3]
C1386553
treatment with remoxipride within 6 months (180 days) prior to visit 1
Beschrijving

Remoxipride

Datatype

boolean

Alias
UMLS CUI [1]
C0073047
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Similar models

Eligibility Schizophrenia NCT00088478

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Schizophrenia | Psychotic episode
Item
patients must have schizophrenia and be experiencing a psychotic episode
boolean
C0036341 (UMLS CUI [1])
C0338614 (UMLS CUI [2])
Comprehension Sufficient Protocol Compliance | Informed Consent
Item
each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
boolean
C0162340 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | olanzapine
Item
patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
female patients must not be pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Genderr Medical condition | Gender Medical condition Serious | Gender Medical condition Unstable | Schizophrenia
Item
female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
boolean
C0079399 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C3843040 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C3843040 (UMLS CUI [3,2])
C0443343 (UMLS CUI [3,3])
C0036341 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
olanzapine Therapeutic procedure Resistant to
Item
patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
boolean
C0171023 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332325 (UMLS CUI [1,3])
Seizures Quantity | Etiology Unresolved
Item
one or more seizures without a clear and resolved etiology is exclusionary. however, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
boolean
C0036572 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1314792 (UMLS CUI [2,1])
C0443342 (UMLS CUI [2,2])
Clozapine
Item
treatment with clozapine within 4 weeks prior to visit 1
boolean
C0009079 (UMLS CUI [1])
Substance Dependence | Nicotine Dependence | Caffeine dependence
Item
dsm-iv or dsm-iv-tr substance (except nicotine and caffeine) dependence within the past 30 days
boolean
C0038580 (UMLS CUI [1])
C0028043 (UMLS CUI [2])
C1386553 (UMLS CUI [3])
Remoxipride
Item
treatment with remoxipride within 6 months (180 days) prior to visit 1
boolean
C0073047 (UMLS CUI [1])
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